Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV

NCT06498401 | Not Yet Recruiting

• 1 other identifier: SZ2024-008
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to conduct a dietary intervention targeting HIV specific gut microbiota alterations for primary atherosclerotic cardiovascular disease (ASCVD) prevention and evaluate its effectiveness in preventing ASCVD among people living with HIV (PLWH). Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months.

Conditions

HIV; Atherosclerosis; Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• ASCVD prediction risk

  The Pooled Cohort Equations (PCE) will be utilized to estimate the 10-year risk of ASCVD. The required data will include age, gender, race, total cholesterol, HDL cholesterol, systolic blood pressure, hypertension treatment status, smoking status, and diabetes status. The PCE is a well-established and validated model for predicting ASCVD risk.

  baseline, 3-month and 6-month

• Gut microbiota diversity and composition

  Fecal samples will be collected from study participants, and the diversity and composition of gut microbiota will be analyzed using 16S rRNA technology.

  baseline and 3-month

Secondary Outcomes (16)

• Blood lipids

  baseline, 3-month and 6-month

• Blood pressure

  baseline, 3-month and 6-month

• BMI

  baseline, 3-month and 6-month

• Waistline

  baseline, 3-month and 6-month

• Hip circumference

  baseline, 3-month and 6-month

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group will receive the gut microbiota targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance for the same duration. The intervention will span three months, followed by a three-month follow up period.

Dietary Supplement: gut microbiota-targeted dietary intervention

control group

NO INTERVENTION

The control group will continue routine follow-up and health education practices.

Interventions

gut microbiota-targeted dietary intervention DIETARY_SUPPLEMENT

The dietary intervention targeted at gut microbiota. Each participant's dietary habits,food preferences and economic level were taken into account. The dietary intervention was delivered by sending meals. To ensure the freshness and quality of the ingredients, 2 dedicated researchers were jointly responsible for the procurement of fresh ingredients, which were purchased through regular channels on Monday, Wednesday and Friday mornings. Meals will be delivered three times a week for a 12-week intervention period. Guided dietary follow-up was conducted through WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance every two weeks.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
• Aged 18 years and above;
• PCE predicted ASCVD risk of 5% - \<20%;
• Those with a predicted survival time of \>1 year;
• No plans to leave the depth in the next 3 months;
• Voluntary participation in this study and signing the informed consent.

You may not qualify if:

• Those with a previous history of CVD;
• Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;
• Currently suffering from malignant tumors, kidney diseases, gastrointestinal diseases; People with an aversion to eating;
• Allergic to nuts and fish;
• People who take medicinal calcium \>1000 mg per day or omega-3 supplements;
• Plan to become pregnant within 6 months;
• Are participating in other HIV-related or dietary intervention-related scientific research programs.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 12, 2024
• Study Start: July 20, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share